# K192100: Aveta Disposable Hysteroscope

- Pathway: 510(k) (Special)
- Applicant: Meditrina, Inc.
- Decided: Dec 19, 2019 after 136 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K950035 (1996). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190372: Aveta System, Meditrina, Inc. (2019) Summary page 4.

## Indications for use
The Aveta Disposable Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K192100
Methodology: https://510kreport.com/methodology
